Senior Process Engineer
Bachelor of Science in Chemical or Mechanical Engineering
Minimum of 5 years of relevant experience within a cGMP environment
Experience in process development, experimental design/statistical analysis, process optimization and scale-up
Familiar with new product introduction, technology transfer, and process/equipment validation
Working knowledge of various manufacturing processes and unit operations including powder/material handling and dispensing, roll compaction, dry blending/milling, tablet compression, and secondary packaging
Basic knowledge of process control systems
Continuous improvement background with knowledge of Lean Manufacturing/Six Sigma/OE tools and techniques
Understanding of Quality by Design (QbD) principles and process analytical technology (PAT)
Experience using coaching/mentoring techniques and interpersonal communication skills in working with a diverse population at all levels of the company (i.e. shop floor to global corporate partners)
Competency in technical writing
Masters in Engineering
7+ years of relevant experience within a cGMP environment
Demonstrated track record of success leading multiple projects simultaneously with minimal direction
Job Description Summary-
Recommends and implements improvements, modifications or additions to document work.
Reviews product development requirements for compatibility with processing methods.
Determines costs and schedules.
Integrates equipment and material capabilities to meet process module target specifications and technology target specifications.
Performs engineering work in operations, production or maintenance environments.
Designs and scales up manufacturing processes, instruments and equipment, and tests manufactured products to maintain quality.
Plans, designs and estimates time and cost, and oversees maintenance of structures, facilities, systems and components. Analyses and develops solutions to engineering problems related to manufacturing equipment and systems or the causes of component failures. Develops and applies engineering standards and procedures, and provides advice on issues within the engineering field.
Serve as a technical lead/product owner for manufacturing process development and continuous improvement activities associated with quality, yield, waste, cycle time, safety, and process robustness across a portfolio of consumer healthcare products in the OTC and oral care categories.
Propose and implement process improvements, monitor process capability, and conduct product performance assessments using statistical analysis to support the Product Lifecycle Management program.
Conduct investigations of process deviations to determine root cause/corrective actions
Perform technical risk assessments and develop product control strategies for assigned products
Author and execute plant trials to resolve process challenges as well as implement new improvements.
Author/revise Batch Records, SOPs, technical reports, technical change controls, and other site documentation
Conduct technical training on processes and procedures to all levels of the organization
Collaborate with R&D to ensure Design for Manufacturing principles are used for optimization of new product/technology introduction
Support both internal and external manufacturing associated with new product introduction and technology transfer programs
Support site functions (i.e. Engineering, EHS, Operations, etc.) with technical expertise including process validation initiatives, engineering capital projects, etc.
Provide support to site process safety program
You may apply for this position online by selecting the Apply now button.
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